FDA Device · 2020
FDA Device recalls in 2020
RecallRadar indexes 3,055 FDA Device recall notices published in 2020. By classification: 182 Class I, 2,804 Class II, 69 Class III.
- SafeStep Huber Needle Set with Y Injection Site and Medegen Needleless Injection Cap
FDA Device · Class II · 2020-07-29 · Becton Dickinson And - syngo.via RT Image Suite with software versions syngo.via VB30 or VB40
FDA Device · Class II · 2020-07-29 · Siemens Medical Solutions Usa - Accurian RF Ablation, Cannula pk, Accurian, 150mm, 20G, 10mm, CS Product Number: AC0012 GTIN / UPN: 20763000153629 - Product Usage: (steril…
FDA Device · Class II · 2020-07-29 · Medtronic Sofamor Danek Usa - LivaNova USA Sterile Disposable Connector,1/2x1/2, 20 units per case
FDA Device · Class III · 2020-07-29 · Livanova Usa - Safe-T-Centesis PLUS 8 Fr Catheter Drainage Tray
FDA Device · Class II · 2020-07-29 · Carefusion 2200 - PowerLoc MAX Power Injectable Infusion Set AllPoints Port Access System
FDA Device · Class II · 2020-07-29 · Becton Dickinson And - PowerLoc MAX Power Injectable Infusion Set with GuardIVa Antimicrobial Hemostatic Dressing Port Access Kit
FDA Device · Class II · 2020-07-29 · Becton Dickinson And - Thora-Para 8 Fr Catheter Drainage Tray
FDA Device · Class II · 2020-07-29 · Carefusion 2200 - Ablation Galil Technology, Three IceFORCE 2.1 CX Prostate Cyroablation Kit Visual ICE System, Prescription Only Galil Medicals 2.1 CX Cryoa…
FDA Device · Class II · 2020-07-29 · Boston Scientific - MEVION S250 Proton Radiation Treatment System
FDA Device · Class II · 2020-07-29 · Mevion Medical Systems - Software 1898072 IPC upgrade v 2.7.3.0 - Product Usage: The IPC system is indicated for the incision/cutting removal, drilling and sawing o…
FDA Device · Class II · 2020-07-29 · Medtronic Xomed - ANAX 5.5 Poly-Reduction Screw 6.0X50MM, REF: SFNA6050R, part of ANAX 5.5 SPINAL SYSTEM
FDA Device · Class II · 2020-07-29 · U And I - Thora-Para 5 Fr Catheter Drainage Tray
FDA Device · Class II · 2020-07-29 · Carefusion 2200 - PowerLoc MAX Power Injectable Infusion Port Access Kit
FDA Device · Class II · 2020-07-29 · Becton Dickinson And - Sysmex PS-10 Sample Preparation System Catalog number:BQ716341 - Product Usage: is a fully automated, user configurable, open system intend…
FDA Device · Class II · 2020-07-29 · Sysmex America - Ablation Galil Technology, IcePearl 2.1 CX 90 Cyroablation Needles, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intend…
FDA Device · Class II · 2020-07-29 · Boston Scientific - Accurian RF Ablation, Cannula pk, Accurian, 100mm, 22G, 5mm, CS Product Number: AC0016 GTIN / UPN: 20763000153674 - Product Usage: (sterile…
FDA Device · Class II · 2020-07-29 · Medtronic Sofamor Danek Usa - Accurian RF Ablation, Cannula pk, Accurian, 100mm, 20G, 10mm, CS Product Number: AC0009 GTIN / UPN: 20763000153599 - Product Usage: (steril…
FDA Device · Class II · 2020-07-29 · Medtronic Sofamor Danek Usa - IntelliVue MX800 patient monitor, model no. 865240
FDA Device · Class II · 2020-07-29 · Philips North America - SafeStep Huber Needle Set with GuardIVa Antimicrobial Hemostatic Dressing Port Access Kit
FDA Device · Class II · 2020-07-29 · Becton Dickinson And - Computed Tomography X-ray System, Model: uCT 550, GTIN: 06971576831036 Intended use The uCT Computed Tomography X-ray System uCT 530/uCT 55…
FDA Device · Class II · 2020-07-29 · Shanghai United Imaging Healthcare - LoFric Origo, Nelaton, 16in, FR10 urinary catheters
FDA Device · Class II · 2020-07-29 · Wellspect Healthcare Division Of Dentsply Ih Ab - Safe-T-Centesis 6 Fr Catheter Drainage Tray w/o Lidocaine
FDA Device · Class II · 2020-07-29 · Carefusion 2200 - Safe-T 8 Fr Thora-Para Tray With 8 Fr. Catheter and Sharps Injury Protection - Drug Free
FDA Device · Class II · 2020-07-29 · Carefusion 2200 - Ablation Galil Technology, IceFORCE 2.1 CX 90 Needle Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are…
FDA Device · Class II · 2020-07-29 · Boston Scientific - Ablation Galil Technology, Three IceFORCE 2.1 Prostate Cyroablation Kit Visual ICE System, Prescription Only Galil Medicals 2.1 CX Cryoabla…
FDA Device · Class II · 2020-07-29 · Boston Scientific - Ablation Galil Technology, IceFORCE 2.1 CX Prostate Kit Visual ICE System, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are…
FDA Device · Class II · 2020-07-29 · Boston Scientific - TRIGEN, Intramedullary nail - Product Usage: is intended to provide resistance for screw back-out
FDA Device · Class II · 2020-07-29 · Smith And Nephew - Ablation Galil Technology, IceFORCE 2.1 CX Needle Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are int…
FDA Device · Class II · 2020-07-29 · Boston Scientific - Safe-T PLUS Thora-Para 5 Fr Catheter Drainage Tray
FDA Device · Class II · 2020-07-29 · Carefusion 2200 - Accurian RF Ablation,Cannula pk, Accurian, 100mm, 22G, 10mm, SS Product Number: AC0019 GTIN / UPN: 20763000153667 - Product Usage: (sterile…
FDA Device · Class II · 2020-07-29 · Medtronic Sofamor Danek Usa - Ablation Galil Technology, IcePearl 2.1 CX Needle Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are int…
FDA Device · Class II · 2020-07-29 · Boston Scientific - Expansion Control Overlay, Item No. 1004EC - Product Usage: The EHOB WAFFLE Overlay is more than a support surface, assisting in lateral tr…
FDA Device · Class II · 2020-07-29 · Ehob - Safe-T 5 Fr Thora-Para Tray With 5 Fr. Catheter and Sharps Injury Protection - Drug Free
FDA Device · Class II · 2020-07-29 · Carefusion 2200 - CRANIOSCULPT, CMF IMPACT, 5CC, Product Number: C-CMF5CC, UDI: 813845020948 - Product Usage: Callos is indicated to fill bony voids or gaps…
FDA Device · Class II · 2020-07-22 · Skeletal Kinetics - BodyGuard Microset, REF: A120-161XYB
FDA Device · Class I · 2020-07-22 · Cme America - CMExpress Microbore Set, REF: A120-160CRV
FDA Device · Class I · 2020-07-22 · Cme America - BodyGuard Microset, REF: A120-161XPSV
FDA Device · Class I · 2020-07-22 · Cme America - ACUMED CALLOS INJECT 5CC. Product Number: 65-0005-S, UDI: 813845020238 - Product Usage: Callos is indicated to fill bony voids or gaps of t…
FDA Device · Class II · 2020-07-22 · Skeletal Kinetics - MEDTRONIC BONE VOID FILLER, SMALL. Product Number: C07A, UDI: 813845020504 - Product Usage: Callos is indicated to fill bony voids or gaps…
FDA Device · Class II · 2020-07-22 · Skeletal Kinetics - SKAFFOLD FLOW, 10CC. Product Number: SKMX-FL10, UDI: 813845020900 - Product Usage: Callos is indicated to fill bony voids or gaps of the sk…
FDA Device · Class II · 2020-07-22 · Skeletal Kinetics - OSTEOVATION, 5CC, IMPACT FORMULA. Product Number: 390-2105, UDI: 813845020085 - Product Usage: Callos is indicated to fill bony voids or ga…
FDA Device · Class II · 2020-07-22 · Skeletal Kinetics - BodyGuard Microset, REF: A120-161XPS
FDA Device · Class I · 2020-07-22 · Cme America - BodyGuard Microset w/ 0.2 mic filter and lower y-site with female luer, REF: A120-160CYFRV
FDA Device · Class I · 2020-07-22 · Cme America - OSTEOVATION, 3CC, IMPACT FORMULA. Product Number: 390-2103, UDI: 813845020078 - Product Usage: Callos is indicated to fill bony voids or ga…
FDA Device · Class II · 2020-07-22 · Skeletal Kinetics - OSTEOVATION, 10CC, INJECT FORMULA. Product Number: 390-2010, UDI: 813845020061 - Product Usage: Callos is indicated to fill bony voids or g…
FDA Device · Class II · 2020-07-22 · Skeletal Kinetics - ACUMED CALLOS INJECT 3CC. Product Number: 65-0003-S, UDI: 813845020221 - Product Usage: Callos is indicated to fill bony voids or gaps of t…
FDA Device · Class II · 2020-07-22 · Skeletal Kinetics - CRANIOSCULPT FLOW, OUS, 5CC Product Number: C-FLOW5CC-OUS, UDI: 813845020351 - Product Usage: Callos is indicated to fill bony voids or gap…
FDA Device · Class II · 2020-07-22 · Skeletal Kinetics - DRW-0739-01: Gen 2 Posterior Chairside Splint LLUR (lower left-upper right) - Product Usage: intended to provide assistance in both the pla…
FDA Device · Class II · 2020-07-22 · Neocis - SKAFFOLD FLOW (MX) 5CC. Product Number: SKMX-FL05, UDI: 813845020894 - Product Usage: Callos is indicated to fill bony voids or gaps of the…
FDA Device · Class II · 2020-07-22 · Skeletal Kinetics - OSTEOVATIONEX 5CC, INJECT FORMULA. Product Number: 390-0005, UDI: 813845020023 - Product Usage: Callos is indicated to fill bony voids or g…
FDA Device · Class II · 2020-07-22 · Skeletal Kinetics - ACUMED IMPACT 10CC. Product Number: 65-0110-S, UDI: 813845020269 - Callos is indicated to fill bony voids or gaps of the skeletal system (i…
FDA Device · Class II · 2020-07-22 · Skeletal Kinetics - MOL3650 Simplexa VZV Direct - Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection of varicella-z…
FDA Device · Class II · 2020-07-22 · Diasorin Molecular - SKAFFOLD CMF IMPRESS (MP), 10CC. Product Number: CMMP-IM10, UDI: 813845020696 - Product Usage: Callos is indicated to fill bony voids or ga…
FDA Device · Class II · 2020-07-22 · Skeletal Kinetics - DRW-0739-02: Gen 2 Posterior Chairside Splint LRUL (lower right-upper left) - Product Usage: intended to provide assistance in both the pla…
FDA Device · Class II · 2020-07-22 · Neocis - BodyGuard Microset with Filter and Manual Priming Valve, REF: A120-112XSFV
FDA Device · Class I · 2020-07-22 · Cme America - BodyGuard Microset, REF: A120-161XYBS
FDA Device · Class I · 2020-07-22 · Cme America - SKAFFOLD CMF IMPRESS (MP), 5CC. Product Number: CMMP-IM05, UDI: 813845020689 - Product Usage: Callos is indicated to fill bony voids or gap…
FDA Device · Class II · 2020-07-22 · Skeletal Kinetics - EXACTECH OSSILIX MP FIL, 10CC. Product Number: 662-02-10, UDI: 813845021051 - Product Usage: Callos is indicated to fill bony voids or gaps…
FDA Device · Class II · 2020-07-22 · Skeletal Kinetics - CRANIOSCULPT C, 3CC. Product Number: C-C3CC, UDI: 813845021105 - Product Usage: Callos is indicated to fill bony voids or gaps of the skele…
FDA Device · Class II · 2020-07-22 · Skeletal Kinetics - BodyGuard Microset, REF: A100-163XSFL
FDA Device · Class I · 2020-07-22 · Cme America - OSTEOVATION IMPACT 10CC and OSTEOVATION, 10CC, IMPACT FORMULA, Product Number: 390-2110, UDI: 813845020092 - Product Usage: Callos is indic…
FDA Device · Class II · 2020-07-22 · Skeletal Kinetics - CRANIOSCULPT, FLOW 5CC. Product Number: C-FLOW5CC, UDI: 813845020337 - Product Usage: Callos is indicated to fill bony voids or gaps of the…
FDA Device · Class II · 2020-07-22 · Skeletal Kinetics - DRW-0742-01: Gen 2 Anterior Chairside Splint LLUR (lower left-upper right) - Product Usage: intended to provide assistance in both the plan…
FDA Device · Class II · 2020-07-22 · Neocis - BodyGuard Microset, REF: A120-160XPS
FDA Device · Class I · 2020-07-22 · Cme America - BodyGuard Microset w/ 0.2 mic filter and lower y-site with female luer, REF: A120-160XYBF
FDA Device · Class I · 2020-07-22 · Cme America - EXACTECH OSSILIX FORM (MX), 5CC. Product Number: 660-01-05, UDI: 813845021020 - Product Usage: Callos is indicated to fill bony voids or ga…
FDA Device · Class II · 2020-07-22 · Skeletal Kinetics - EXACTECH OSSILIX FIL (MX), 5CC. Product Number: 660-02-05, UDI: 813845021006 - Product Usage: Callos is indicated to fill bony voids or gap…
FDA Device · Class II · 2020-07-22 · Skeletal Kinetics - EXACTECH OSSILIX FIL (MX), 10CC. Product Number: 660-02-10, UDI: 813845021013 - - Product Usage: Callos is indicated to fill bony voids or…
FDA Device · Class II · 2020-07-22 · Skeletal Kinetics - SKAFFOLD RENU FLOW, 10CC. Product Number: SKMA-FL10, UDI: 813845020856 - Product Usage: Callos is indicated to fill bony voids or gaps of t…
FDA Device · Class II · 2020-07-22 · Skeletal Kinetics - Standard BodySet with Needleless Connectors, REF: A120-125XS
FDA Device · Class I · 2020-07-22 · Cme America - ACUMED CALLOS INJECT 10CC. Product Number: 65-0010-S, UDI: 813845020245 - Product Usage: Callos is indicated to fill bony voids or gaps of…
FDA Device · Class II · 2020-07-22 · Skeletal Kinetics - MEDTRONIC BONE VOID FILLER, LARGE. Product Number: C07B, UDI: 813845020511 - Product Usage: Callos is indicated to fill bony voids or gaps…
FDA Device · Class II · 2020-07-22 · Skeletal Kinetics - BodyGuard Microset with Filter, REF: A120-160XSFE
FDA Device · Class I · 2020-07-22 · Cme America - BodyGuard Microset with Filter, REF: A100-164XESF
FDA Device · Class I · 2020-07-22 · Cme America - BodyGuard Microset w/ Non-Vented Spike Connector, REF: A100-163XEBS
FDA Device · Class I · 2020-07-22 · Cme America - CRANIOSCULPT C, 10CC. Product Number: C-C10CC, UDI: 813845021129 - Product Usage: Callos is indicated to fill bony voids or gaps of the ske…
FDA Device · Class II · 2020-07-22 · Skeletal Kinetics - BodyGuard Microset, REF: A120-160GCFA
FDA Device · Class I · 2020-07-22 · Cme America - BodyGuard Microset with Male Luer Connectors, REF: A100-163XEBF
FDA Device · Class I · 2020-07-22 · Cme America - OSTEOVATIONEX, INJECT 3CC. Product Number: 390-0003, UDI: 813845020016 - Product Usage: Callos is indicated to fill bony voids or gaps of t…
FDA Device · Class II · 2020-07-22 · Skeletal Kinetics - SKAFFOLD RENU FLOW, 5CC. Product Number: SKMA-FL05, UDI: 813845020849 - Product Usage: Callos is indicated to fill bony voids or gaps of th…
FDA Device · Class II · 2020-07-22 · Skeletal Kinetics - BodyGuard Microset, REF: A100-163XESV
FDA Device · Class I · 2020-07-22 · Cme America - POWERWAND XL 4Fr 8cm Maximum Barrier Kit (Introducer with an Extended Dwell Catheter made of ChronoFlex C with BioGUARD Technology), Catalo…
FDA Device · Class III · 2020-07-22 · Access Scientific - BodyGuard Microset, REF: A120-160XYSF
FDA Device · Class I · 2020-07-22 · Cme America - BodyGuard Microset, REF: A100-163XSL
FDA Device · Class I · 2020-07-22 · Cme America - CRANIOSCULPT FLOW, OUS, 10CC. Product Number: C-FLOW10CC-OUS, UDI: 813845020382 - Product Usage: Callos is indicated to fill bony voids or…
FDA Device · Class II · 2020-07-22 · Skeletal Kinetics - enVista one-piece hydrophobic acrylic toric intraocular lens, Bausch and Lomb - Product Usage: is indicated for primary implantation in the…
FDA Device · Class II · 2020-07-22 · Bausch And Lomb Surgical - EXACTECH OSSILIX FORM (MX), 10CC. Product Number: 660-01-10, UDI: 813845021037 - Product Usage: Callos is indicated to fill bony voids or g…
FDA Device · Class II · 2020-07-22 · Skeletal Kinetics - MagNA Pure 96 Instrument, clinical sample concentrator, Material number 06541089001 - Product Usage: This protocol is intended for pipettin…
FDA Device · Class II · 2020-07-22 · Roche Molecular Systems - BodyGuard Microset, REF: A120-160X2YB
FDA Device · Class I · 2020-07-22 · Cme America - Trinias DAP Meter, a component of the Digital Anglo System Trinias contained within the DAR-9500f - Product Usage: It is intended to be use…
FDA Device · Class II · 2020-07-22 · Shimadzu Medical Systems - MOL2150 Simplexa HSV 1&2 Direct -CSF -Genital Swab -Cutaneous / Mucocutaneous Swabs Product Usage: is intended for use on the LIAISON MDX i…
FDA Device · Class II · 2020-07-22 · Diasorin Molecular - BodyGuard Microset, REF: A120-125XSE
FDA Device · Class I · 2020-07-22 · Cme America - ACUMED IMPACT 5CC. Product Number: 65-0105-S, UDI: 813845020252 - Product Usage: Callos is indicated to fill bony voids or gaps of the skel…
FDA Device · Class II · 2020-07-22 · Skeletal Kinetics - CMExpress Microbore Set, REF: A120-161CYF
FDA Device · Class I · 2020-07-22 · Cme America - BodyGuard set with Female Luer, REF: A120-003XSN
FDA Device · Class I · 2020-07-22 · Cme America - CMExpress Microbore Sets, REF: A120-160CYFRV
FDA Device · Class I · 2020-07-22 · Cme America - BodyGuard Microset, REF: A100-163XE90S
FDA Device · Class I · 2020-07-22 · Cme America - CRANIOSCULPT FLOW, 3CC. Product Number: C-FLOW3CC, UDI: 813845020320 - - Product Usage: Callos is indicated to fill bony voids or gaps of t…
FDA Device · Class II · 2020-07-22 · Skeletal Kinetics - OSTEOVATION, 5CC, INJECT FORMULA. Product Number: 390-2005, UDI: 813845020054 - Product Usage: Callos is indicated to fill bony voids or ga…
FDA Device · Class II · 2020-07-22 · Skeletal Kinetics
Other years
2026 (2,024) · 2025 (2,908) · 2024 (3,393) · 2023 (2,477) · 2022 (2,191) · 2021 (2,303) · 2020 (3,055) · 2019 (2,801) · 2018 (3,757) · 2017 (2,615) · 2016 (3,246) · 2015 (2,495) · 2014 (3,059) · 2013 (2,249) · 2012 (1,310)